BioMark Diagnostics Receives Clearance From Health Canada to Commence Clinical Trial With Patented Non-Invasive, Urine-Based Assay to Measure Response to Treatment for Lung Cancer

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VANCOUVER, British Columbia, Sept. 9, 2015 - BioMark Diagnostics Inc. (“BioMark”) ($BUX:CNX) (FSE:20B) ($BMKDF) announces receipt of a No Objection Letter from Health Canada, clearing the way for a clinical trial with the company’s metabolite-based assay using a urine sample to measure response to treatment for lung cancer.

The trial will specifically look at lung cancer and response to treatment while the company continues its ongoing Phase III trial for BioMark’s early stage, low cost general screening test which currently has 200 samples preparing to be analyzed.

The trial will recruit patients with lung cancer who are being treated with chemotherapeutics with enrollment expected to begin during the fourth quarter of 2015.  Dr. Andrew Maksymiuk, Medical Oncologist at CancerCare Manitoba and Professor in the Faculty of Medicine at the University of Manitoba, will be the principal investigator. In 2014, Dr. Maksymiuk was awarded the Joan K. Mauer Memorial Quality Assurance Award by the Cancer Therapy Evaluation Program of the U.S. National Cancer Institute. Dr. Daniel Sitar, Professor Emeritus in the Faculty of Medicine at the University of Manitoba, will serve as co-principal investigator.  The trial will be conducted at CancerCare Manitoba along with the clinical support from the staff at Saint Boniface Research Centre located in Winnipeg, Manitoba.

“Lung cancer is North America’s most deadly cancer, and the ability to use clinical biomarkers to assess a patient’s response to chemotherapeutics can be highly effective for quickly developing and managing a time-sensitive, personalized treatment regime,” said BioMark’s President and CEO Rashid Ahmed. “A faster treatment prognosis allows a doctor to course correct or guide a treatment plan when time is of the essence.  The result would be very beneficial to a patient, medical community and the paying institutions.”

“Our patented assay, which uses a urine sample, can be easily adopted into routine clinical practice,” added Mr. Ahmed. “This clinical trial is one of several steps we are taking to bring this technology to physicians and their patients, and to reinforce BioMark as a life-saving brand. We are honored to have Drs. Maksymiuk and Sitar leading this clinical trial.”

About BioMark’s Non-Invasive, Urine-Based Assay

BioMark’s assay consists of screening for the acetylated form of the drug Amantadine given to patients prior to measurement via LC MS in body fluids. This acetylation is performed by the enzyme Spermine/Spermidine N-Acetyl Transferase (SSAT). It has been documented that elevated levels of SSAT are observed in many cancers including lung, breast, prostate, melanoma and gastric cancers. Clinical trials conducted with both cancer and healthy subjects have provided proof of principle. In addition, analysis of SSAT mRNA levels in tissue samples allows determination of cancer type.

About BioMark Diagnostics Inc.

BioMark Diagnostics is developing proprietary, non-invasive, and accurate cancer diagnostic solutions, which can help detect, monitor and assess treatment for cancer early and cost effectively. The technology can also be used for measuring response to treatment and potentially for serial monitoring for cancer survivors.  Please visit www.biomarkdiagnostics.com.

Further information about BioMark Diagnostics is available under its profile on the SEDAR website www.sedar.com, on the CSE website www.thecse.ca and at www.biomarkdiagnostics.com.

Forward-Looking Information

This press release may include forward-looking information within the meaning of Canadian securities legislation, concerning the business of BioMark. Forward-looking information is based on certain key expectations and assumptions made by the management of BioMark. Although BioMark believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because BioMark can give no assurance that they will prove to be correct. Forward-looking statements contained in this press release are made as of the date of this press release. BioMark disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws. We seek safe harbor

The CSE has not reviewed, approved or disapproved the content of this press release.

Company Contact
Rashid Ahmed Bux
President & CEO
BioMark Diagnostics Inc.
604-282-6567


Investor Contact
LHA
Jody Cain
310-691-7100

 

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